Agency Information Collection Activities: Submission for OMB Review; Comment Request, 31840-31841 [E7-10985]
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31840
Federal Register / Vol. 72, No. 110 / Friday, June 8, 2007 / Notices
Responses: 6,050; Total Annual Hours:
42,350.
3. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Medicare
Authorization to Disclose Personal
Health Information; Form Number:
CMS–10106 (OMB#: 0938–931); Use:
Unless permitted or required by law,
§ 164.508 of the Standards for Privacy of
Individually Identifiable Health
Information final rule (67 FR 53182)
prohibits Medicare, a Health Insurance
Portability and Accountability (HIPAA)
covered entity, from disclosing an
individual’s protected health
information without a valid
authorization. In order to be valid, an
authorization must include specified
core elements and statements. Medicare
will make available to Medicare
beneficiaries a standard, valid
authorization to enable beneficiaries to
request the disclosure of their protected
health information. This standard
authorization will simplify the process
of requesting information disclosure for
beneficiaries and minimize the response
time for Medicare. The completed
authorization will allow Medicare to
disclose an individual’s personal health
information to a third party at the
individual’s request. Frequency:
Reporting—On occasion; Affected
Public: Individuals or households;
Number of Respondents: 1,000,000;
Total Annual Responses: 1,000,000;
Total Annual Hours: 250,000.
4. Type of Information Collection
Request: Revision of a currently
approved collection. In this revision, a
number of changes were made to the
form and accompanying instructions to
facilitate the completion and data entry
of the form. Specifically, the
enumeration of individuals involved in
laboratory testing was eliminated, and
the reporting of hours of laboratory
operations was streamlined. Some fields
were expanded to reflect changes in
laboratory demographics (added prison
and assisted living facility to location of
laboratory testing) and to collect
complete information on the number of
tests performed in laboratories. There
are no program changes; Title of
Information Collection: Clinical
Laboratory Improvement Amendments
Application Form and Supporting
Regulations at 42 CFR 493.1–2001; Form
Number: CMS–116 (OMB#: 0938–0581);
Use: The application must be completed
by entities performing laboratory’s
testing specimens for diagnostic or
treatment purposes. This information is
vital to the certification process.
Frequency: Reporting—Biennially;
Affected Public: Business or other for-
VerDate Aug<31>2005
18:14 Jun 07, 2007
Jkt 211001
profit and Not-for-profit institutions;
Number of Respondents: 187,000; Total
Annual Responses: 17,960; Total
Annual Hours: 22,450.
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS’ Web Site
address at https://www.cms.hhs.gov/
PaperworkReductionActof1995, or Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov, or call the
Reports Clearance Office on (410) 786–
1326.
To be assured consideration,
comments and recommendations for the
proposed information collections must
be received at the address below, no
later than 5 p.m. on August 7, 2007.
CMS, Office of Strategic Operations
and Regulatory Affairs, Division of
Regulations Development—C, Attention:
Bonnie L Harkless, Room C4–26–05,
7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
Dated: May 31, 2007.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. E7–10984 Filed 6–7–07; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10137, CMS–
10069 and CMS–R–246]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Centers for Medicare &
Medicaid Services, HHS.
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Centers for Medicare & Medicaid
Services (CMS), Department of Health
and Human Services, is publishing the
following summary of proposed
collections for public comment.
Interested persons are invited to send
comments regarding this burden
estimate or any other aspect of this
collection of information, including any
of the following subjects: (1) The
necessity and utility of the proposed
information collection for the proper
performance of the Agency’s function;
(2) the accuracy of the estimated
burden; (3) ways to enhance the quality,
utility, and clarity of the information to
AGENCY:
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be collected; and (4) the use of
automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
1. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Application for
Prescription Drug Plans (PDP);
Application for Medicare Advantage
Prescription Drug (MA–PD);
Application for Cost Plans to Offer
Qualified Prescription Drug Coverage;
Application for Employer Group Waiver
Plans to Offer Prescription Drug
Coverage; Service Area Expansion
Application for Prescription Drug
Coverage; Use: Collection of this
information is mandated in Part D of the
Medicare Prescription Drug,
Improvement, and Modernization Act of
2003. The application requirements are
codified in Subpart K of 42 CFR part
423. Coverage for the prescription drug
benefit is provided through prescription
drug plans (PDPs) that offer drug-only
coverage, or through Medicare
Advantage (MA) organizations that offer
integrated prescription drug and health
care coverage (MA–PD plans). PDPs
must offer a basic drug benefit.
Medicare Advantage Coordinated Care
Plans (MA–CCPs) must offer either a
basic benefit or may offer broader
coverage for no additional cost.
Medicare Advantage Private Fee for
Service Plans (MA–PFFS) may choose to
offer a Part D benefit. Cost Plans that are
regulated under Section 1876 of the
Social Security Act, and Employer
Group Plans may also provide a Part D
benefit. If any of the contracting
organizations meet basic requirements,
they may also offer supplemental
benefits through enhanced alternative
coverage for an additional premium.
The information will be collected
under the solicitation of proposals from
PDP, MA–PD, Cost Plan, and Employer
Group Waiver Plans applicants. The
collected information will be used by
CMS to: (1) Insure that applicants meet
CMS requirements, and (2) support the
determination of contract awards.
The major program change that has
occurred in Part D applications was that
CMS removed several attestations
related to Health Insurance Portability
and Accountability Act (HIPAA), bids
and privacy; Form Number: CMS–10137
(OMB#: 0938–0936); Frequency:
Reporting: Once; Affected Public:
Business or other for-profit and Not-forprofit institutions; Number of
Respondents: 857; Total Annual
Responses: 857; Total Annual Hours:
28,122.
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pwalker on PROD1PC71 with NOTICES
Federal Register / Vol. 72, No. 110 / Friday, June 8, 2007 / Notices
2. Type of Information Collection
Request: Extension without change of a
currently approved collection; Title of
Information Collection: Medicare
Waiver Demonstration Application; Use:
The Medicare Waiver Demonstration
Application will be used to collect
standard information needed to
implement congressionally mandated
and administration high priority
demonstrations. The application will be
used to gather information about the
characteristics of the applicant’s
organization, benefits, and services they
propose to offer, success in operating
the model, and evidence that the model
is likely to be successful in the Medicare
program. The standard application will
be used for all waiver demonstrations
and will reduce the burden on
applicants, provide for consistent and
timely information collections across
demonstrations, and provide a userfriendly format for respondents; Form
Number: CMS–10069 (OMB#: 0938–
0880); Frequency: Reporting: Once;
Affected Public: Business or other forprofit and Not-for-profit institutions;
Number of Respondents: 75; Total
Annual Responses: 75; Total Annual
Hours: 6000.
3. Type of Information Collection
Request: Extension without change of a
currently approved collection; Title of
Information Collection: Medicare
CAHPS Survey; Use: The collection of
Consumer Assessment of Healthcare
Providers and Systems (CAHPS) Survey
measures is necessary to hold health
and prescription drug plans accountable
for the quality of care and services they
deliver. This requirement will allow
CMS to obtain information for the
proper oversight of the program. This
information is used to help beneficiaries
choose among plans, contribute to
improved quality of care through
identification of quality improvement
opportunities, and assist CMS in
carrying out its responsibilities; Form
Number: CMS–R–246 (OMB#: 0938–
0732); Frequency: Reporting: Yearly;
Affected Public: Individuals or
households; Number of Respondents:
660,000; Total Annual Responses:
660,000; Total Annual Hours: 217,800.
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS Web Site
address at https://www.cms.hhs.gov/
PaperworkReductionActof1995, or Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov, or call the
Reports Clearance Office on (410) 786–
1326.
VerDate Aug<31>2005
18:14 Jun 07, 2007
Jkt 211001
Written comments and
recommendations for the proposed
information collections must be mailed
or faxed within 30 days of this notice
directly to the OMB desk officer: OMB
Human Resources and Housing Branch,
Attention: Carolyn Lovett, New
Executive Office Building, Room 10235,
Washington, DC 20503, Fax Number:
(202) 395–6974.
Dated: May 31, 2007.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. E7–10985 Filed 6–7–07; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
31841
Consultants Staff (HFD–21), Food and
Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
7001, e-mail:
jayne.peterson@fda.hhs.gov.
Section
120 of the FDA Modernization Act of
1997 (FDAMA) (21 U.S.C. 355) requires
that newly formed FDA advisory
committees include representatives
from the drug manufacturing industries.
Although not required for committees
existing prior to the passage of FDAMA,
to keep within the spirit of FDAMA, the
agency has added nonvoting industry
representatives to CDER advisory
committees identified in the following
paragraphs.
SUPPLEMENTARY INFORMATION:
I. CDER Advisory Committees
Food and Drug Administration
Request for Notification From Industry
Organizations Interested in
Participating in Selection Process for
Nonvoting Industry Representatives on
Public Advisory Committees and
Request for Nominations for
Nonvoting Industry Representatives on
Public Advisory Committees
1. Advisory Committee for
Pharmaceutical Science and Clinical
Pharmacology (Formerly Advisory
Committee for Pharmaceutical Science)
Advises on scientific and technical
issues concerning the safety and
effectiveness of human generic drug
products for use in the treatment of a
broad spectrum of human diseases.
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is requesting that
any industry organizations interested in
participating in the selection of
nonvoting industry representatives to
serve on its public advisory committees
for the Center for Drug Evaluation
Research (CDER) notify FDA in writing.
FDA is also requesting nominations for
nonvoting industry representatives to
serve on CDER’s public advisory
committees. A nominee may either be
self-nominated or nominated by an
organization to serve as a nonvoting
industry representative. Nominations
will be accepted for current vacancies
effective with this notice.
DATES: Any industry organization
interested in participating in the
selection of an appropriate nonvoting
member to represent industry interests
must send a letter stating that interest to
FDA by July 9, 2007, for vacancies listed
in this notice. Concurrently, nomination
materials for prospective candidates
should be sent to FDA by July 9, 2007.
ADDRESSES: All letters of interest and
nominations should be submitted in
writing to Jayne Peterson (see FOR
FURTHER INFORMATION CONTACT).
FOR FURTHER INFORMATION CONTACT:
Jayne Peterson, Advisors and
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2. Advisory Committee for Reproductive
Health Drugs
Reviews and evaluates available data
concerning the safety and effectiveness
of marketed and investigational human
drug products for use in obstetrics,
gynecology, and contraception.
3. Anesthetic and Life Support Drugs
Advisory Committee
Reviews and evaluates available data
concerning the safety and effectiveness
of marketed and investigational human
drug products for use in anesthesiology
and surgery.
4. Anti-Infective Drugs Advisory
Committee
Reviews and evaluates available data
concerning the safety and effectiveness
of marketed and investigational human
drug products for use in the treatment
of infectious diseases and disorders.
5. Antiviral Drugs Advisory Committee
Reviews and evaluates available data
concerning the safety and effectiveness
of marketed and investigational human
drug products for use in the treatment
of acquired immune deficiency
syndrome (AIDS), HIV-related illnesses,
and other viral, fungal, and
mycobacterial infections.
6. Arthritis Advisory Committee
Reviews and evaluates available data
concerning the safety and effectiveness
of marketed and investigational human
E:\FR\FM\08JNN1.SGM
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]]>Agencies
[Federal Register Volume 72, Number 110 (Friday, June 8, 2007)]
[Notices]
[Pages 31840-31841]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-10985]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-10137, CMS-10069 and CMS-R-246]
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
AGENCY: Centers for Medicare & Medicaid Services, HHS.
In compliance with the requirement of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid
Services (CMS), Department of Health and Human Services, is publishing
the following summary of proposed collections for public comment.
Interested persons are invited to send comments regarding this burden
estimate or any other aspect of this collection of information,
including any of the following subjects: (1) The necessity and utility
of the proposed information collection for the proper performance of
the Agency's function; (2) the accuracy of the estimated burden; (3)
ways to enhance the quality, utility, and clarity of the information to
be collected; and (4) the use of automated collection techniques or
other forms of information technology to minimize the information
collection burden.
1. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Application for
Prescription Drug Plans (PDP); Application for Medicare Advantage
Prescription Drug (MA-PD); Application for Cost Plans to Offer
Qualified Prescription Drug Coverage; Application for Employer Group
Waiver Plans to Offer Prescription Drug Coverage; Service Area
Expansion Application for Prescription Drug Coverage; Use: Collection
of this information is mandated in Part D of the Medicare Prescription
Drug, Improvement, and Modernization Act of 2003. The application
requirements are codified in Subpart K of 42 CFR part 423. Coverage for
the prescription drug benefit is provided through prescription drug
plans (PDPs) that offer drug-only coverage, or through Medicare
Advantage (MA) organizations that offer integrated prescription drug
and health care coverage (MA-PD plans). PDPs must offer a basic drug
benefit. Medicare Advantage Coordinated Care Plans (MA-CCPs) must offer
either a basic benefit or may offer broader coverage for no additional
cost. Medicare Advantage Private Fee for Service Plans (MA-PFFS) may
choose to offer a Part D benefit. Cost Plans that are regulated under
Section 1876 of the Social Security Act, and Employer Group Plans may
also provide a Part D benefit. If any of the contracting organizations
meet basic requirements, they may also offer supplemental benefits
through enhanced alternative coverage for an additional premium.
The information will be collected under the solicitation of
proposals from PDP, MA-PD, Cost Plan, and Employer Group Waiver Plans
applicants. The collected information will be used by CMS to: (1)
Insure that applicants meet CMS requirements, and (2) support the
determination of contract awards.
The major program change that has occurred in Part D applications
was that CMS removed several attestations related to Health Insurance
Portability and Accountability Act (HIPAA), bids and privacy; Form
Number: CMS-10137 (OMB: 0938-0936); Frequency: Reporting:
Once; Affected Public: Business or other for-profit and Not-for-profit
institutions; Number of Respondents: 857; Total Annual Responses: 857;
Total Annual Hours: 28,122.
[[Page 31841]]
2. Type of Information Collection Request: Extension without change
of a currently approved collection; Title of Information Collection:
Medicare Waiver Demonstration Application; Use: The Medicare Waiver
Demonstration Application will be used to collect standard information
needed to implement congressionally mandated and administration high
priority demonstrations. The application will be used to gather
information about the characteristics of the applicant's organization,
benefits, and services they propose to offer, success in operating the
model, and evidence that the model is likely to be successful in the
Medicare program. The standard application will be used for all waiver
demonstrations and will reduce the burden on applicants, provide for
consistent and timely information collections across demonstrations,
and provide a user-friendly format for respondents; Form Number: CMS-
10069 (OMB: 0938-0880); Frequency: Reporting: Once; Affected
Public: Business or other for-profit and Not-for-profit institutions;
Number of Respondents: 75; Total Annual Responses: 75; Total Annual
Hours: 6000.
3. Type of Information Collection Request: Extension without change
of a currently approved collection; Title of Information Collection:
Medicare CAHPS Survey; Use: The collection of Consumer Assessment of
Healthcare Providers and Systems (CAHPS) Survey measures is necessary
to hold health and prescription drug plans accountable for the quality
of care and services they deliver. This requirement will allow CMS to
obtain information for the proper oversight of the program. This
information is used to help beneficiaries choose among plans,
contribute to improved quality of care through identification of
quality improvement opportunities, and assist CMS in carrying out its
responsibilities; Form Number: CMS-R-246 (OMB: 0938-0732);
Frequency: Reporting: Yearly; Affected Public: Individuals or
households; Number of Respondents: 660,000; Total Annual Responses:
660,000; Total Annual Hours: 217,800.
To obtain copies of the supporting statement and any related forms
for the proposed paperwork collections referenced above, access CMS Web
Site address at https://www.cms.hhs.gov/PaperworkReductionActof1995, or
E-mail your request, including your address, phone number, OMB number,
and CMS document identifier, to Paperwork@cms.hhs.gov, or call the
Reports Clearance Office on (410) 786-1326.
Written comments and recommendations for the proposed information
collections must be mailed or faxed within 30 days of this notice
directly to the OMB desk officer: OMB Human Resources and Housing
Branch, Attention: Carolyn Lovett, New Executive Office Building, Room
10235, Washington, DC 20503, Fax Number: (202) 395-6974.
Dated: May 31, 2007.
Michelle Shortt,
Director, Regulations Development Group, Office of Strategic Operations
and Regulatory Affairs.
[FR Doc. E7-10985 Filed 6-7-07; 8:45 am]
BILLING CODE 4120-01-P
